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Marketed Unapproved Drugs; Public Workshop

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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Food and Drug Administration, HHS.


Notice of public workshop.


The Food and Drug Administration (FDA) is announcing a public workshop on issues related to the application process for seeking approval for marketed unapproved drugs. This will be a 1-day workshop involving FDA staff and representatives from businesses currently marketing unapproved drugs. The purpose of the workshop is to provide clarification and direction to businesses on how to seek approval to legally market drugs through the new drug application (NDA) and abbreviated new drug application (ANDA) processes and how to legally market drugs through compliance with the over-the-counter (OTC) monographs.


The public workshop will be held on January 9, 2007, from 9 a.m. to 4 p.m. Registration is open until November 15, 2006. Submit requests for specific discussion topics by November 15, 2006. -


The public workshop will be held in the Center for Drug Evaluation and Research Advisory Committee conference room, 5630 Fishers Lane, rm. 1066, Rockville, MD. The agenda for the meeting will be posted at​cder/​drug/​unapproved_​drugs.

Submit topics by mail to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit topics electronically to​dockets/​ecomments. Submit two paper copies of any mailed topics, except that individuals may submit one paper copy. All requests for discussion topics should be identified with the docket number found in brackets in the heading of this document.

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Karen Kirchberg, Center for Drug Evaluation and Research (HFD-330), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-8916, e-mail:

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I. Background

In the Federal Register of June 9, 2006 (71 FR 33466), FDA announced the availability of a guidance entitled “Marketed Unapproved Drugs—Compliance Policy Guide” (the Marketed Unapproved Drugs CPG). The guidance describes how FDA intends to exercise its enforcement discretion with regard to drugs marketed in the United States that do not have required FDA approval for marketing. The guidance explains that FDA intends to continue to give priority to enforcement actions involving unapproved drugs that have potential safety risks, lack evidence of effectiveness, and constitute health fraud, among other categories. The Marketed Unapproved Drugs CPG also explains how the agency intends to address those situations in which a company obtains approval to sell a drug that other companies have sold without FDA approval for some time. In the Marketed Unapproved Drugs CPG, FDA encourages companies to comply with the drug approval requirements of the Federal Food, Drug, and Cosmetic Act.

Following the publication of the Marketed Unapproved Drugs CPG, a number of drug companies have contacted FDA seeking clarification about how to obtain approval to legally market their unapproved drug products and whether applications for marketing are subject to user fees, among other issues. The agency is committed to working with companies to facilitate the process of ensuring that products are safe and effective and meet appropriate standards for manufacturing and labeling.

II. Scope of the Public Workshop

As part of FDA's goal to ensure that all marketed drugs comply with appropriate FDA requirements to ensure their safety and efficacy, FDA is holding a public workshop to educate businesses on the drug application and OTC monograph processes and to discuss issues of interest to participants.

Topics for discussion include the following: (1) The various routes for legal marketing—NDAs, ANDAs, and OTC monographs; (2) application processes; (3) user fee applicability and waivers; and (4) market exclusivity for newly-approved drugs. The information provided during registration will help us determine additional topics for discussion and how to further focus the workshop.

III. Participation in the Public Workshop

A. Registration

Register via e-mail to by providing complete contact information for each attendee (including name, title, affiliation, e-mail address, and phone number(s)) by November 15, 2006. Please indicate “Workshop—Unapproved Products” in the “subject” line of the e-mail. FDA intends to respond to registration requests by e-mail after November 15, 2006. There is no registration fee to attend. Space is limited; therefore, interested parties are encouraged to register early and FDA may need to limit the number of attendees from each firm or organization. If you need special accommodations due to a disability, please e-mail your request at least 7 days before the meeting.

B. Suggested Topics

If you would like to request discussion of a specific topic for the workshop, submit it to the Division of Dockets Management (see ADDRESSES) using the docket number, found in brackets in the heading of this document, by November 15, 2006. We may not be able to include all submitted topics in the workshop agenda.

C. Parking, Transportation, and Security

Limited visitor parking is available for a fee, and the Twinbrook Metro station is within walking distance. Early arrival is encouraged, as there will be security screening. Workshop participants will be asked for government-issued picture identification by the security officers.

IV. Transcripts

Following the workshop, transcripts will be available for review at the Start Printed Page 64285Division of Dockets Management (see ADDRESSES), Monday through Friday between 9 a.m. and 4 p.m. You may also request a copy of the transcript from the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857, approximately 15 working days after the public workshop at a cost of 10 cents per page.

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Dated: October 20, 2006.

Jeffrey Shuren,

Assistant Commissioner for Policy.

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[FR Doc. E6-17959 Filed 10-31-06; 8:45 am]